Odwala a Lebrikizumab Amapeza Chilolezo cha Khungu kuchokera ku monotherapy

Oposa 50 peresenti ya odwala omwe ali ndi vuto la atopic dermatitis (AD) adachepetsa kuchepa kwa matenda (EASI-75*) ndi 75 peresenti pa masabata 16 pamene akulandira lebrikizumab monotherapy mu pulogalamu ya Advocate, Eli Lilly and Company (NYSE). : LLY) adalengeza lero ku Msonkhano Wapachaka wa American Academy of Dermatology (AAD). Lebrikizumab, inhibitor yofufuza ya IL-13, idapangitsanso kuti pakhale kusintha kwabwino kwa itch ndi zotsatira zina zofunika za odwala poyerekeza ndi placebo.

"Odwala atopic dermatitis amakumana ndi kuyabwa kosalekeza, khungu louma, kupweteka kwambiri ndi kutupa, zomwe sizingadziwike komanso zimakhudza ntchito yawo, maubwenzi, malingaliro ndi malingaliro," adatero Emma Guttman-Yassky, MD, Ph.D., pulofesa wa Waldman. ndi mpando wapampando wa Dermatology ku Icahn School of Medicine ku Mount Sinai ku New York, komanso wolemba wamkulu wa Advocate akuwunika. "Lebrikizumab ndi chithandizo chamakono chomwe chimayang'ana njira ya IL-13, yomwe ndiyomwe imayendetsa cytokine yotupa yomwe imakhudzidwa ndi AD. Ndimalimbikitsidwa ndi zomwe zakhala zikuchitika masiku ano zomwe zikuwonetsa kusintha kwachangu pakhungu, kuyabwa komanso moyo wabwino. ”

Lebrikizumab ndi monoclonal antibody (mAb) yomwe imamangiriza ku mapuloteni a interleukin 13 (IL-13) omwe ali ndi kuyanjana kwakukulu kuti ateteze makamaka mapangidwe a IL-13Rα1 / IL-4Rα (Mtundu wa 2 receptor) omwe amaletsa kutsika kwapansi kudzera mu IL-13. njira. 1-5 IL-13 imagwira ntchito yaikulu mu kutupa kwa mtundu wa 2 Mu AD, IL-6 imayang'ana zizindikiro ndi zizindikiro kuphatikizapo kuwonongeka kwa khungu, kuyabwa, matenda ndi madera olimba a khungu.13

Mu Advocate 1, 43 peresenti ya odwala omwe amalandila lebrikizumab adapeza khungu loyera kapena lowoneka bwino (IGA) pamasabata a 16 poyerekeza ndi 13 peresenti ya odwala omwe amamwa placebo. Mwa omwe amalandila lebrikizumab, 59 peresenti adapeza yankho la EASI-75, poyerekeza ndi 16 peresenti yokhala ndi placebo.

Mu Advocate 2, 33 peresenti ya odwala omwe amamwa lebrikizumab adapeza khungu loyera kapena loyera (IGA) pakatha milungu 16, poyerekeza ndi 11 peresenti ya odwala omwe ali ndi placebo. Mwa omwe adalandira lebrikizumab, 51 peresenti adapeza yankho la EASI-75, poyerekeza ndi 18 peresenti yomwe idatenga placebo.

Pasanathe milungu inayi, odwala omwe amalandila lebrikizumab adawona kusintha kwakukulu pakhungu ndi kuyabwa, komanso kusintha kwa kusokoneza kuyabwa pakugona, komanso moyo wabwino, monga momwe amawonera kumapeto kwachiwiri.

Mbiri yachitetezo cha nthawi ya masabata 16 inali yogwirizana ndi maphunziro am'mbuyomu a lebrikizumab mu AD. Odwala omwe amatenga lebrikizumab, poyerekeza ndi placebo, adanenanso zocheperapo za zochitika zoyipa mu Advocate 1 (lebrikizumab: 45%, placebo: 52%) ndi Advocate 2 (lebrikizumab: 53%, placebo: 66%). Zochitika zoyipa kwambiri pamaphunziro awiriwa zinali zofatsa kapena zolimbitsa thupi komanso zopanda pake ndipo sizinapangitse kusimitsidwa kwamankhwala. Zomwe zimachitika kwambiri mu Advocate 1 ndi 2 kwa omwe ali pa lebrikizumab zinali conjunctivitis (7% ndi 8%, motsatana), chimfine (nasopharyngitis) (4% ndi 5%, motsatana) ndi mutu (3% ndi 5%, motsatana). ).

"Zomwe anthu amakumana nazo komanso kulimbana ndi matenda a autoimmune, monga atopic dermatitis, zimatipangitsa ife ku Lilly kutsatira sayansi yatsopano komanso chithandizo chamankhwala chomwe chimapangitsa moyo kukhala wabwino, makamaka m'malo omwe akufunika kufunikira kofunikira," adatero Lotus Mallbris, MD, Ph.D. ., Wachiwiri kwa Purezidenti wa Global immunology Development and Medical Affairs ku Lilly. "Zotsatirazi zimalimbikitsa zotsatira zabwino mu pulogalamu yathu yachitukuko ya Gawo 3, ndipo tikukhulupirira kuti lebrikizumab ikuyimira mbadwo watsopano wa biologics wa AD."

Zotsatira zatsatanetsatane zamasabata 52 zochokera kwa Advocate 1 ndi 2, komanso deta ya masabata 16 kuchokera ku ADhere, kafukufuku wa Phase 3 AD wa lebrikizumab wokhala ndi topical steroids, adzawululidwa m'miyezi ikubwerayi. Lilly ndi Almirall SA akukonzekera kutumiza zikalata kwa oyang'anira padziko lonse lapansi kumapeto kwa 2022 akamaliza maphunziro a Advocate.

"Odwala amafunikira njira zatsopano zochizira zomwe zimapereka mphamvu komanso kulekerera. Deta zabwino izi zikuwonetsa kuti lebrikizumab imatha kukhala chithandizo chotsogola mu AD, "atero Karl Ziegelbauer, Ph.D., Chief Scientific Officer wa Almirall.

Lilly ali ndi ufulu wokhazikika wachitukuko ndi malonda a lebrikizumab ku United States ndi padziko lonse lapansi kunja kwa Europe. Almirall ali ndi chilolezo chopanga ndi kugulitsa lebrikizumab pochiza zisonyezo za dermatology, kuphatikiza AD, ku Europe.